保元颗粒制备工艺研究

Study on preparation process of Baoyuan Granules

目的:优选保元颗粒的制备工艺。方法:建立超高效液相-蒸发光散射检测(UPLC-ELSD)法同步测定人参皂苷Rb1与黄芪甲苷含量。以人参皂苷Rb1与黄芪甲苷转移率为评价指标,正交试验考察提取时间、提取次数、溶剂倍数对保元汤提取工艺的影响,观察浸膏相对密度对干燥工艺的影响。选用湿法制粒,以成型率、休止角、吸湿率、堆密度、溶化性为评价指标,考察辅料、润湿剂等对制粒的影响,优化保元颗粒的成型工艺。结果:优选的最佳提取工艺为加水量10倍,提取2次,每次1 h。喷雾干燥时浸膏的相对密度确定为1.05~1.15。最佳成型工艺以麦芽糊精为辅料,麦芽糊精与干膏粉用量比例为1∶1,以90%乙醇为湿润剂进行湿法制粒。结论:优化的保元颗粒制备工艺稳定、可行,可为保元颗粒的生产提供参考。

Objective:To optimize the preparation process of Baoyuan Granules.Methods:An ultra-high performance liquid chromatography-evaporative light scattering detection(UPLC-ELSD) method was established for the simultaneous determination of ginsenoside Rb;and astragaloside Ⅳ. Taking the transfer rates of ginsenoside Rb;and astragaloside Ⅳ as evaluation indexes,the effects of extraction time,extraction times and solvent volume on the extraction process of Baoyuan decoction were investigated by orthogonal test,and the effect of relative density of extractum on the drying process was observed. Based on wet granulation,taking the molding rate,angle of repose,moisture absorption rate,bulk density and solubility as evaluation indexes,the effects of excipients and wetting agents on the granulation were investigated,and the molding process of Baoyuan Granules was optimized.Results:The optimum extraction process was as follows:the amount of water was 10 times,twice extraction and one hour each time. The relative density of the extractum was determined to be 1.05 to 1.15 during spray drying. The optimum molding process was wet granulation with maltodextrin as excipient and 90% ethanol as wetting agent,the dosage ratio of maltodextrin to dry paste powder was 1∶1.Conclusion:The optimized preparation process of Baoyuan Granules is stable and feasible,which can provide reference for the production of Baoyuan Granules.